ROSA One 3 — Class I medical device recall Z-0118-2022
Ongoing recall by MEDTECH SAS, reported 2021-11-03, distributed nationwide. The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inac
| Recall number | Z-0118-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDTECH SAS, Montpellier, N/A, France |
| Recall initiated | 2021-09-22 |
| Classified | 2021-10-25 |
| Reported by FDA | 2021-11-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, IN, JP, KR, NL, TH, TW |
| Reason classes | software |
| Serial numbers | BS15902, BS15903, BS16007, BS16904, BS16905, BS16906, BS16909, BS16910, BS16911, BS16912, BS16913, BS16914, BS16915, BS16916, BS16917, BS16918, BS16919, BS16921, BS16923, BS16925, BS16928, BS16929, BS17008, BS17010, BS17013 and 149 more |
Product
ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.
Reason for recall
The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0118-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.